Allergan Announces FDA Approval of Label Extensions for JUVEDERM Ultra and JUVEDERM Ultra Plus
IRVINE, Calif. -- Allergan, Inc., the maker of BOTOX® Cosmetic (Botulinum Toxin Type A), today announced approval by the U.S. Food and Drug Administration (FDA) of label extensions for JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus based on new clinical data demonstrating that the effects of both products may last for up to one year, which is longer than reported in clinical studies that supported FDA approval of other hyaluronic acid (HA) dermal fillers.
"Patients are looking for longer-lasting, science-based products that fill in lines, such as the parentheses around the mouth, as part of their overall anti-aging skin care regimen," said Robert Grant, President of Allergan Medical, a division of Allergan. "We are pleased to provide physicians with the only HA dermal filler products currently approved in the United States to provide smooth, natural looking results lasting up to one year with a single treatment."
Mark Pinsky, M.D., a West Palm Beach, Fla.-based plastic surgeon and a clinical investigator in the study that supported the label extensions, said, "The results of this study are exciting because they establish JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus as the only HA dermal fillers approved on the market today to have proven persistence up to one year, which is an important attribute to patients. Most patients and physicians want fillers that are long-lasting and reversible - unlike semi-permanent or permanent products - because they provide a natural look that can be adjusted over time as the face changes."
JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus are the only HA dermal fillers developed using the proprietary HYLACROSS(TM) technology, a technologically advanced manufacturing process that results in a malleable, smooth gel that flows easily into the skin and creates a smooth, natural look and feel. All other HA dermal fillers currently on the market have a granular consistency gel. These granules can be seen under 2.4X magnification as opposed to the smooth consistency gel of the JUVEDERM(TM) family of products.
About the Study
The JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus label extensions are based on long-term, follow-up data evaluating the longevity of clinical improvement for up to 1.5 years after treatment in 225 patients that originally participated in a six-month, multi-center, double blind, randomized pivotal study evaluating the safety and effectiveness of JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus.
The original, pivotal study included 292 subjects who were randomly assigned treatment with JUVEDERM(TM) Ultra or JUVEDERM(TM) Ultra Plus in one nasolabial fold (NLF) and ZYPLAST® bovine collagen in the other NLF. NLFs were graded on a 5-point Wrinkle Assessment Scale (from 0 = no wrinkle to 5 = extreme, deep wrinkle with overlapping skin) together with a validated photographic guide. At the six month end of the pivotal trial, the mean improvement was clinically significant (greater than or equal to 1-point improvement from baseline) with JUVEDERM(TM) Ultra or JUVEDERM(TM) Ultra Plus treatment - but not with ZYPLAST®.
After completion of the pivotal trial, subjects could return for a complimentary follow-up treatment, at which time their NLF scores were again evaluated. More than three-quarters of JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus pivotal study participants (79% and 76%, respectively) returned for repeat treatment. The mean level of improvement remained clinically significant for a large majority of the subjects who returned at 6-9 months as well as for those who returned beyond 9 months (84% and 92% at 6-9 months, and 75% and 81% beyond 9 months with JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus, respectively). Additionally, 23 JUVEDERM(TM) Ultra Plus subjects returned more than 48 weeks (1 year) after their last injection and of these, 78% had maintained improvement.
A subset of 48 subjects were then enrolled in a second study that followed subjects for 6-12 months after repeat treatment. Throughout the year-long follow-up period, JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus provided clinically significant improvement in NLF severity, with a large majority of subjects demonstrating improvement at 6 months and beyond. At 6 months after repeat treatment, 87% of subjects treated with JUVEDERM(TM) Ultra and 91% of subjects treated with JUVEDERM(TM) Ultra Plus had maintained improvement. At 1 year after repeat treatment, 78% of JUVEDERM(TM) Ultra subjects and 90% of JUVEDERM(TM) Ultra Plus subjects had maintained improvement.
During the studies, no subjects discontinued treatment due to lack of effectiveness or adverse events and no serious treatment-related adverse events were reported with any of the fillers. The frequency and severity of treatment site reactions was similar for all the fillers, with the majority of treatment site reactions lasting seven days or less. There were no treatment-related adverse events other than those localized to the area of injection and in general site reactions were mild or moderate in severity and did not require intervention.
This study was sponsored by Allergan.
Important JUVEDERM(TM) Dermal Filler Safety Information
JUVEDERM(TM) is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds), and is generally well tolerated. In clinical studies, adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common side effects included temporary injection site reactions including redness, pain/tenderness, firmness, swelling, lumps and bumps and bruising. For complete patient safety and prescribing information, please visit www.Juvederm.com.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
About Allergan Medical
Allergan Medical, a division of Allergan, Inc., offers the most comprehensive, science-based, aesthetic product offerings under its Total Facial Rejuvenation portfolio, including BOTOX® Cosmetic; hyaluronic acid and collagen-based dermal fillers; and physician-dispensed skin care products. Allergan Medical also offers the industry's widest range of breast implant options for reconstructive and aesthetic breast surgery, and leading minimally invasive devices for obesity intervention treatment.
Forward-Looking Statements
This press release contains "forward-looking statements", including the statements by Dr. Pinsky and Mr. Grant, statements regarding research and development outcomes, efficacy, market and product potential and other statements regarding JUVEDERM(TM) dermal fillers. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients and the potential for product failures; unknown risks associated with the investigational devices that are the subject of Allergan's clinical trials; potential difficulties in manufacturing new products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law.
Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2006 Form 10-K and Allergan's Form 10-Q for the quarter ended March 30, 2007. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.